BICAFRES (sodium bicarbonate) - Metabolic acidosis in adults and adolescents aged 14 years and older
Reason for request
First assessment.
Key points
Favourable opinion for reimbursement in the treatment of metabolic acidosis in adults and adolescents aged 14 years and older with chronic renal failure.
What therapeutic improvement?
No clinical added value in the therapeutic strategy.
Role in the care pathway?
CKD is the most common cause of chronic metabolic acidosis. Metabolic acidosis is defined as a plasma bicarbonate level of below 23 mmol/l. Metabolic acidosis has major clinical consequences if left untreated, and can accelerate the progression of kidney disease, bone disease and, above all, cardiac problems related, among other things, to the risk of hyperkalaemia.
The treatment of metabolic acidosis in chronic kidney disease schedules:
- an alkalising diet (KDOQI 2020);
- in the absence of sodium overload: 3 to 6 g of sodium bicarbonates per day;
- investigation for and correction of hyperkalaemia (bicarbonates in the form of Vichy water or sodium bicarbonates can correct both disorders);
- in the event of severe acute acidosis (pH < 7.20 and bicarbonate < 10 mmol/l): emergency hospitalisation for IV infusion of sodium bicarbonates or renal dialysis.
Role of the medicinal product:
BICAFRES (sodium bicarbonate) is a first-line medicinal product in the treatment of metabolic acidosis in patients with CKD.
Clinical Benefit
Substantial |
The clinical benefit of BICAFRES (sodium bicarbonate) is substantial in the MA indication. |
Clinical Added Value
no clinical added value |
Considering:
the Transparency Committee deems that BICAFRES (sodium bicarbonate) provides no clinical added value (CAV V) in the care pathway for metabolic acidosis in the context of chronic renal failure. |